Improving Family Meetings in the Pediatric Cardiac Intensive Care Unit

NCT03749330 | Completed Results DMC

• 2 other identifiers: 15-012274K23HL141700
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to improve communication between medical teams, patients, and families in the pediatric cardiac intensive care unit. The researchers hypothesize that both improving interprofessional teamwork when preparing for family meeting and preparing families for these meetings will improve team and family satisfaction with communication. The study will involve bringing together a group of medical professionals and parents of patients to collaboratively design an intervention. In addition, the researchers will study feasibility and acceptability of the intervention and whether it impacts family and team outcomes.

Conditions

Communication; Critical Illness

Keywords

cardiac intensive care unit; pediatrics; medical communication

Outcome Measures

Primary Outcomes (11)

• Perceived Acceptability Comparison of CICU TALC by CICU Providers Immediately After Completion of Intervention: Satisfaction Survey

  Acceptability of the study will be evaluated with 1 item from the Satisfaction with and Impact of the Course survey. The item is whether the training would be recommended to colleagues scored using a 4-point Likert scale (1=strongly agree to 4=strongly disagree), therefore a lower score indicates more acceptability.

  5 months

• Participant Retention Rates

  Retention rates will be tracked over time by comparing numbers of enrolled/retained subjects to numbers of those who decline to enroll or disenroll

  3.5 years

• Participant Consent Rates

  Consent rates will be tracked over time by comparing numbers of consenting subjects to numbers of subjects who do not consent to participate

  3.5 years

• Rates of Missing Data From Parents and Team Subjects

  Percent of missing data from parent and CICU team member reported survey data will be tracked throughout the study. All participants should have had data collected, therefore denominator is number of participants and the numerator is the number of participants that we received survey data from.

  3.5 years

• Duration of Meetings Between Teams and Families

  Meetings will be audio-recorded and the length of each meeting measured automatically as part of analysis with NVivo qualitative coding software

  3.5 years

• Amount of Information Provided by CICU TALC as Perceived by Parent Participants in Intervention

  Parent participant perception of acceptability of the amount of information included in the intervention will be assessed with the amount of information item from the Patient Ratings of Shared Decision Making Program scale. Response options range from 1-3 on a 3-point Likert scale (1=less than wanted, about right, 3=more than wanted).

  2 years

• Perceived Clarity of Intervention Materials of CICU TALC by Parent Participants in Intervention

  Parent participant perception of clarity of intervention materials will be assessed with the clarity item from the Patient Ratings of Shared Decision Making Program scale. Response options range from 1-3 on a 3-point Likert scale (1=everything clear, most things clear, 3=some/many things unclear).

  2 years

• Summary Rating of CICU TALC Intervention by Parent Participants in Intervention

  Overall parent participant perception of the intervention will be assessed with the summary rating of intervention item from the Patient Ratings of Shared Decision Making Program scale. Response options range from 1-5 on a 5-point Likert scale (1=very positive, generally positive, neutral, somewhat positive, 5=very negative).

  2 years

• Percent of Family Meetings Adhering to Intervention Protocol

  For the 30 family meetings which were intended to receive the intervention (CST) we will assess the percent of those meetings which met the threshold of adhering to the intervention protocol. The denominator is the total number of observed MEETINGS in the post-intervention phase and the numerator is the number of meeting that meet the adherence threshold.

  2 years

• Percent of Team Meetings Adhering to Intervention Schedule and Protocol: Observation of Meeting

  Percent of Team interactions post-intervention will be monitored to assess the adherence to the intervention schedule and protocol.

  2 years

• Feasibility of Enrollment and Retention of Participants

  Were we able to enroll clinicians in the intervention portion of the study and parents in the study and to what extent were they retained throughout the duration of the study.

  2 years

Secondary Outcomes (2)

• Changes in CICU Providers' Use of Explicit Statements of Empathy During Family Meetings

  2 years

• Changes in CICU Team Function for Communication

  2 years

Study Arms (1)

CHOP CICU

OTHER

CICU Team And Loved Ones Communicating (CICU TALC)

Behavioral: CICU Team And Loved Ones Communicating (CICU TALC)

Interventions

CICU Team And Loved Ones Communicating (CICU TALC) BEHAVIORAL

When the necessary pre-intervention clinical encounters are completed, clinicians will go through the interprofessional team training to improve communication skills and teamwork in developing care plans and communicating with families in family meetings. The first step in the study is co-design of the intervention, so it will evolve as the study continues.

CHOP CICU

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in Co-design:
• \- Clinicians including attending physicians, front line clinicians (fellows, nurse practitioners, or physician assistants), bedside nurses, and social workers working at CHOP or parents of children previously hospitalized in an ICU at CHOP.
• Clinicians Participating in Intervention:
• \- Pediatric CICU clinicians (attending intensivists, cardiologists, cardiac surgeons, front line clinicians, bedside nurses, and social workers) at CHOP who volunteer to undergo communication skills training.
• Clinicians Not Participating in Intervention:
• \- Clinicians who plan to participate in family meetings in the pediatric CICU that will be observed by the research team.
• Parent-patient Dyads Participating in the Survey or Interview:
• Parent must be the legal decision maker of a patient who has been admitted to the CHOP CICU for at least 7 days.
• Patient has been admitted to the CICU at CHOP for ≥7 days following onset of study and the medical team believes the patient will remain in the CICU for at least 7 more days OR the patient has already been admitted to the CICU for 14 days.
• Parent/guardian ≥ 18 years old.
• Child \< 18 years old at time of enrollment.
• Parent/guardian is English-speaking.
• Parent/guardian has no cognitive impairments that prevent them from being a surrogate decision maker.

You may not qualify if:

• Participants in Co-design:
• \- None.
• Clinicians Participating in Intervention:
• \- Clinicians who will not participate in CHOP's CICU chronic care meeting in the following year.
• Clinicians Not Participating in Intervention:
• \- None.
• Parent-patient Dyads Participating in the Survey or Interview:
• Parent is not the legal decision maker of a patient who has been admitted to the CHOP CICU for at least 7 days.
• The medical team does not believe the patient will remain in the CICU for at least 7 more days.
• Parent/guardian \< 18 years old.
• Child is ≥ 18 years old at time of enrollment.
• Parent/guardian is not English-speaking.
• Parent/guardian has cognitive impairments that prevent them from being a surrogate decision maker.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (11)

• Mercer LM, Tanabe P, Pang PS, Gisondi MA, Courtney DM, Engel KG, Donlan SM, Adams JG, Makoul G. Patient perspectives on communication with the medical team: pilot study using the Communication Assessment Tool-Team (CAT-T). Patient Educ Couns. 2008 Nov;73(2):220-3. doi: 10.1016/j.pec.2008.07.003.

  PMID: 18703306 BACKGROUND

• Pyke-Grimm KA, Degner L, Small A, Mueller B. Preferences for participation in treatment decision making and information needs of parents of children with cancer: a pilot study. J Pediatr Oncol Nurs. 1999 Jan;16(1):13-24. doi: 10.1177/104345429901600103.

  PMID: 9989013 BACKGROUND

• Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.

  PMID: 3080166 BACKGROUND

• Creamer M, Bell R, Failla S. Psychometric properties of the Impact of Event Scale - Revised. Behav Res Ther. 2003 Dec;41(12):1489-96. doi: 10.1016/j.brat.2003.07.010.

  PMID: 14705607 BACKGROUND

• Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091.

  PMID: 2084735 BACKGROUND

• Epstein D, Unger JB, Ornelas B, Chang JC, Markovitz BP, Moromisato DY, Dodek PM, Heyland DK, Gold JI. Psychometric evaluation of a modified version of the family satisfaction in the ICU survey in parents/caregivers of critically ill children*. Pediatr Crit Care Med. 2013 Oct;14(8):e350-6. doi: 10.1097/PCC.0b013e3182917705.

  PMID: 23863815 BACKGROUND

• Back AL, Arnold RM, Baile WF, Fryer-Edwards KA, Alexander SC, Barley GE, Gooley TA, Tulsky JA. Efficacy of communication skills training for giving bad news and discussing transitions to palliative care. Arch Intern Med. 2007 Mar 12;167(5):453-60. doi: 10.1001/archinte.167.5.453.

  PMID: 17353492 BACKGROUND

• Dechairo-Marino AE, Jordan-Marsh M, Traiger G, Saulo M. Nurse/physician collaboration: action research and the lessons learned. J Nurs Adm. 2001 May;31(5):223-32. doi: 10.1097/00005110-200105000-00002.

  PMID: 11388158 BACKGROUND

• Baggs JG. Development of an instrument to measure collaboration and satisfaction about care decisions. J Adv Nurs. 1994 Jul;20(1):176-82. doi: 10.1046/j.1365-2648.1994.20010176.x.

  PMID: 7930118 BACKGROUND

• Barry MJ, Fowler FJ Jr, Mulley AG Jr, Henderson JV Jr, Wennberg JE. Patient reactions to a program designed to facilitate patient participation in treatment decisions for benign prostatic hyperplasia. Med Care. 1995 Aug;33(8):771-82. doi: 10.1097/00005650-199508000-00003.

  PMID: 7543639 BACKGROUND

• Clayton JM, Adler JL, O'Callaghan A, Martin P, Hynson J, Butow PN, Laidsaar-Powell RC, Arnold RM, Tulsky JA, Back AL. Intensive communication skills teaching for specialist training in palliative medicine: development and evaluation of an experiential workshop. J Palliat Med. 2012 May;15(5):585-91. doi: 10.1089/jpm.2011.0292. Epub 2012 Mar 20.

  PMID: 22433021 BACKGROUND

MeSH Terms

Conditions

Communication; Critical Illness

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a pilot pre-post study that was conducted with all pre-intervention data collected prior to March 2020 and all intervention and post-intervention data collected during COVID.

Results Point of Contact

• Title: Jennifer Walter, MD, PhD, MS Associate Professor of Pediatrics
• Organization: Children's Hospital of Philadelphia

walterj1@chop.edu

215-590-1000

Study Officials

• Jennifer K Walter, MD, PhD, MS

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 21, 2018
• Study Start: December 19, 2018
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: January 18, 2024
• Results First Posted: January 18, 2024

Record last verified: 2023-12

Locations

US (1)